| CTRI Number |
CTRI/2021/06/033985 [Registered on: 04/06/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
understanding the effect periodontal treatment on type 2 diabetes mellitus subjects |
|
Scientific Title of Study
|
Effect of Non Surgical Periodontal therapy in patients with Periodontitis and Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swet Nisha |
| Designation |
Assistant Professor |
| Affiliation |
Haldia Institute of Dental Sciences and Research,Division Of Dentistry,Department Of Periodontology |
| Address |
Haldia Institute of Dental Sciences and Research,Division Of Dentistry,Department Of Periodontology
haldia institute of dental sciences and research
Medinipur
WEST BENGAL
721645
India |
| Phone |
09883916227 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savan Sunari Rajaram |
| Designation |
Professor |
| Affiliation |
Haldia Institute of Dental Sciences and Research,Division Of Dentistry,Department Of Periodontology |
| Address |
haldia institute of dental sciences and research
haldia institute of dental sciences and research
Medinipur
WEST BENGAL
721645
India |
| Phone |
7595800724 |
| Fax |
|
| Email |
drsavanshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swet Nisha |
| Designation |
Assistant Professor |
| Affiliation |
Haldia Institute of Dental Sciences and Research,Division Of Dentistry,Department Of Periodontology |
| Address |
haldia institute of dental sciences and research
haldia institute of dental sciences and research
Medinipur
WEST BENGAL
721645
India |
| Phone |
09883916227 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Haldia Institute of dental sciences and research |
|
|
Primary Sponsor
|
| Name |
Haldia Institute of dental sciences and research |
| Address |
Haldia Institute of dental sciences and research,Haldia |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swet Nisha |
Haldia Institute of dental sciences and research |
Haldia Institute of dental sciences and research,Division-Dentistry,Department of Periodontology
Medinipur
WEST BENGAL |
9883916227
swetnisha1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Haldia Institute of dental sciences and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
clinical periodontal parameters, salivary biomarker |
Plaque index, Modified gingival index, Probing depth,Bleeding on probing, Recession, Loss of attachment will be measured using UNC 15 probe. |
| Comparator Agent |
non surgical periodontal therapy in type 2 diabetes mellitus patients with and without periodontitis |
All study participants will be instructed in oral hygiene using the modified Bass technique. Periodontal therapy will be performed at baseline by removal supragingival deposits (plaque and calculus) using an ultrasonic scaler . In addition, patients will be treated by full mouth debridement, which will consist of scaling and root planning (SRP) in test group of diabetes mellitus with periodontitis. HbA1c value and Fasting blood glucose levels will be recorded at baseline and at last 12 months-visit, oral hygiene instructions will be repeated in each visits. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with Gingivitis : full mouth bleeding on probing less than 10% of sites.
Subjects with Periodontitis : Subjects with Periodontitis with interdental clinical attachment
loss detectable at >- 2 non adjacent teeth .Buccal or oral clinical attachment loss >-3 mm
with pocketing > 3mm is detectable at >-2 teeth.
Subjects with Periodontally Healthy (PH) : Subjects with PH will have no history of periodontitis, no sites with PD and CAL > 3 mm concurrently and no more than 10% of the sites with gingival bleeding and/or BoP.
Diabetic subjects :The diabetic subjects will require a diagnosis of DM confirmed by a physician, dating from at least 2 years prior to the study. In addition, all diabetic patients will be required to have a HbA1c > 6.5% and FPG > 99 mg/dl.
Non-diabetics: Non-diabetic subjects will have no history of DM, HbA1c ≤ 6.0% and FPG < 99 mg/dl.
|
|
| ExclusionCriteria |
| Details |
Pregnancy; breastfeeding; subgingival periodontal therapy during the previous 12 months; use of antibiotic, anti-inflammatory, and/or immunosuppressive therapies during the previous 6 months; regular use of mouthrinses containing antimicrobials; use of orthodontic
appliances; presence of other infectious, immunological, and/or inflammatory systemic conditions (e.g., immunological disorders, rheumatoid arthritis) and major complications of DM (i.e.,ulcers, gangrene, amputation, neuropathy, and nephropathy),smokers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in clinical periodontal status, salivary biomakers level and markers of diabetes control |
at 3, 6 and 12 months after non surgical periodontal therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral health behaviour and Quality of life assessment |
3,6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/06/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
trial not started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this will be a single centre,parallel arm , investigator masked clinical trial in type 2 diabetes mellitus patients with periodontitis .aim of the study is to evaluate role of periodontal treatment on gylcaemic control.clinical periodontal parameter ,salivary biomarker and HBA1c are the variables to measure the treatment outcomes.this will be 12 months follow up study . |